Methods of Treating Constipation by Administration of Nerve Growth Factor

Abstract

Method for administering nerve growth factor to treat various psychological conditions such as of depression, bi-polar disorders, anxiety disorders, panic attacks, agoraphobia, and attention deficit syndrome, and alleviate symptoms associated with premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), sleep disorders, tension headaches, and constipation that arise as complications from a psychological condition. Also provided are methods of treating constipation comprising administering nerve growth factor in amount effective to treat constipation. Pharmaceutical compositions for the treatment of constipation comprising nerve growth factor are also provided.

Description

RELATED APPLICATIONS [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10 / 624,328, which was filed Jul. 22, 2003, which claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 60 / 424,443, which was filed Nov. 7, 2002, the disclosures of which are incorporated herein by reference in their entireties.FIELD OF THE INVENTION [0002] The present invention relates to methods for treatment of psychological conditions and also treatment of constipation by administration of nerve growth factor. BACKGROUND OF THE INVENTION [0003] The present invention provides methods for treatment of psychological conditions. Such psychological conditions, including major depression, hypomania, cyclothymia, anxiety, bipolar disorder, insomnia and other sleep disorders, hyperactivity, attention deficit disorder, chronic fatigue syndrome, premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and agoraphobia, take an enormous toll on peopl...

AI Technical Summary

Benefits of technology

[0034] The present invention provides methods for treating psychological conditions by administering nerve growth factor. Specifically, the invention provides methods for alleviating symptoms of a psychological condition such as depression, bi-polar disor

Problems solved by technology

Such psychological conditions, including major depression, hypomania, cyclothymia, anxiety, bipolar disorder, insomnia and other sleep disorders, hyperactivity, attention deficit disorder, chronic fatigue syndrome, premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and agoraphobia, take an enormous toll on people's ability to work, maintain relationships, communicate effectively, think properly, perform physical activity, and sense the environment around them.

Unfortunately, up to 30% of patients with major depression do not gain substantial benefit from initial antidepressant treatments.

ECT, however, is accompanied by severe side effects, such as long-lasting memory impairment (Hyman et al., Merks Manual of Medicine, Chapter 13 page 13 (2000)).

These symptoms cause distress and the individual has difficulty functioning in everyday activities.

The cause and maintenance of these symptoms are often due to one of the following problems: loss of a friend, substantial disappointment at work or home, prolonged or chronic illness, and alcohol or drug abuse.

People who suffer from dysthymia are at an increased risk for episodes of major depression.

Depression in the elderly is infrequently diagnosed and untreated due to the fact many older individuals do not admit to the signs or symptoms of depression.

People with this type, however, may also experience episodes of major depression.

In the depressive phase, there is loss of self-esteem, withdrawal, sadness, and a risk of suicide.

While in either phase, patients may abuse alcohol or other substances, which worsens the symptoms.

Fatigue, irritable mood, sleeping difficulties, decreased concentration, sexual problems, and nightmares are also common.

Treatment with benzodiazepines, however, is accompanied by fatigue, drowsiness, and unsteadiness.

Symptoms of panic disorder include shortness of breath, dizziness, palpitations, trembling, sweating, choking, nausea, numbness, chest pain, hot flashes or chills, fear of dying, fear of losing control, and fear of going insane.

Symptoms of agoraphobia include anxiety about being in places where escape might be difficult, fear of being alone, fear of losing control in a public place, feeling of helplessness, and feelings of detachment.

As discussed above, the disadvantage of these therapies is possible drug dependence, harmful side effects, and costs.

These symptoms, combined with a patient already suffering from depression, place these patients at a significantly higher risk of committing suicide during the latter half of their menstrual cycle.

These therapies have demonstrated efficacy in controlling PMDD, but require continuous pharmacotherapy throughout the menstrual cycle, which increases the side effects and costs of these treatments.

Intermittent treatments of PMDD with medication administered daily only during the luteal phase (e.g., for 14 days premenstrually) is being studied, but at present has not been implemented.

Symptoms include developmentally inappropriate levels of attention, concentration, activity, distractibility, and impulsivity.

Despite much progress in the diagnosis and treatment of ADD, the treatment for this disorder remains highly controversial.

The disadvantage of these drugs is the lack of long term information on the affect these drugs have on the cognitive and emotional development of ADD children.

In addition, medications such as antidepressants, tranquilizers, and caffeine have met with little success.

Studies using these techniques have yielded mixed results and no studies have been carried out combining psychological interventions with stimulant medications.

If untreated, depression or other psychological conditions can lead to further complications over a period of time directly dependent upon the severity of depression or psychological condition.

There is usually an increased risk of problems with physical and emotional health, which can lead to premature death due to an accentuated medical illness.

Depression also increases the risk of tobacco dependence and / or alcohol abuse and / or drug-related problems.

A sleep disorder is a disruptive pattern of sleep that may include difficulty falling or staying asleep, falling asleep at inappropriate times, excessive total sleep time, or abnormal behaviors associated with sleep.

Symptoms of sleep disruptive behaviors are depressed mood, anxiety, apathy, difficulty concentrating, irritability, daytime fatigue, drowsiness, and difficulty falling asleep.

Any activity that causes the head to be held in one position can cause a headache.

There is no current treatment that has proven to be effective in curing chronic fatigue syndrome.

When the stool is hard, infrequent, and requires significant effort to pass, the person has constipation.

Constipation may cause discomfort with passage of stools, and passage of large, wide stools may tear the mucosal membrane of the anus, especially in children, causing bleeding and the possibility of an anal fissure.

The problem of such treatment is NGF does not pass through the blood-brain barrier in physiologically relevant amounts and treatments required intracranial surgery (Kordower et al., Exp. Neurol. 124:21-30 (1993).